December 3-4, 2008 | Bethesda, Maryland
Overview
Join members of the PDA Task Force on PDA Technical Report No. 1 and industry representatives at the workshop on PDA Technical Report No. 1, 2007 Revision – Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control to discuss the recommendations in the 2007 revision. The product of new contributions and original text revisions by 40 contributors with scientific and regulatory backgrounds, the 2007 revision of PDA Technical Report No. 1 contains consensus scientific best practices and recommendations on how to establish a moist heat sterilization program that may be applied globally.
PDA’s original Technical Monograph No. 1, Validation of Steam Sterilization Cycles, first published in 1978, introduced the principles of steam sterilization to an entire generation of pharmaceutical scientists and engineers. This revision retains the focus on the general approach to sterilization science contained in the original document, while updating it to include contemporary subject matter on the microbiology, thermal science and engineering of moist heat sterilization. PDA Technical Report No. 1 presents recommendations for best practices in a logical progression from the essential elements of sterilization science and technology through sterilization cycle design, development and ongoing control.
Please bring your copy of the revised PDA Technical Report No. 1 with you to the workshop. The report may also be purchased onsite for $75 (PDA members) or $120 (non-members).
Who Should Attend
Departments
Manufacturing | Formulation | Compliance | Engineering | QA/QC | Development | Regulatory Affairs | Packaging | Research and Development | Technical Operations | Validation | Supply Chain Management
Level of Expertise
Senior Management | Senior Scientists | Project/Program Leader | Technical Contributor
Job Function
Materials scientists | Packaging engineers | Analytical chemists | Toxicologists | Formulators | Product and Process engineers | Regulatory | Biotechnology | Development | Procurement
Learning Objectives
At the end of this meeting, participants will be able to:
- Explain the applied science and technology underlying moist heat sterilization
- Methodically evaluate an existing moist heat sterilization program
- Select the most appropriate moist heat sterilization process for your specific application
- Develop a new moist heat sterilization program
- Assure adequate cycle control and change documentation
- Explain the principles of physical and biological process performance qualification
- Establish a moist heat sterilization policy which addresses all major elements
Venue
PDA Global Headquarters
Bethesda Towers
4350 East West Highway, Suite 150
Bethesda, MD 20814 USA
Tel: +1 (301) 656-5900
Fax: +1 (301) 986-1093
Workshop fees
| Member |
$1,250 |
| Nonmember * |
$1,635 |
| Government/Health Authority |
$520 |
| Academic ** |
$520 |
| Student ** |
$197 |
To register for this please click here to get the registration form (coming soon).
* Registration fee includes a one-year PDA membership. No additional payment is required.
** Must be a PDA member to receive this rate.
Contact
For conference information, contact:
Jason Brown
Programs Manager
Tel: +1 (301) 656-5900 ext. 131
Fax: +1 (301) 986-0296
Email: brown@pda.org
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